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> I find your argument invalid. If they get an approval from FDA, is it going to change their data processing logic or data set?

I guess it would depend on if the FDA finds their data processing logic to result in valid and reliable medical determinations, right?

They also might have to change their marketting materials to comply, something specifically mentioned in the FDA letters. Regulation to prevent misleading marketting of medical products is definitely a pretty core part of the FDA's remit.

If they get an FDA approval, it would mean that there has been review that their outputs are actually appropriate. That's why the FDA is required by law to review items marketed for diagnosing disease.

> If they get an approval from FDA, is it going to change their data processing logic or data set?

It (or the marketing) would have to change if they don't get an approval. That's the whole point.